Urinary incontinence (UI), the involuntary loss of urine, is estimated to affect approximately one in three adult women. Due to such factors as pregnancy and childbirth, menopause, and the structure of the female urinary tract, UI is twice as prevalent in women as in men. UI can also arise from such causes as neurologic injury, birth defects, stroke, multiple sclerosis, and due to physical problems associated with aging and overweight. UI can run the gamut from slightly bothersome to completely debilitating: some women suffering from UI lose a few drops of urine during activities such as running or coughing, while others may feel a strong, sudden urge to urinate just before losing a large amount of urine. For some women suffering from UI, the risk of public embarrassment can keep them from enjoying activities with family and friends.
Stress urinary incontinence (SUI), also known as effort incontinence, is typified by loss of small amounts of urine associated with movements that increase the intra-abdominal pressure, thereby increasing the pressure on the bladder. If the support provided to the urethra by the fascia of the pelvis is insufficient, the two main mechanisms that cause SUI are weakening of connective tissue (fascia) and sphincter dysfunction. In these cases SUI typically occurs at times of increased intra-abdominal pressure, for example, during movements such as coughing, laughing, sneezing, and exercise that increase the intra-abdominal pressure. Such increased intra-abdominal pressure causes the pressure on the urinary bladder to increase, but due to the insufficient urethra support the urethral pressure remains unchanged, which allows urine to pass through the urethra.
While SUI is not an inevitable consequence of aging, SUI is more common in older women than in younger women. This is because striated muscle fibers and the firmness of the endopelvic fascia decrease with age, thereby decreasing the effectiveness of the sphincteric and support systems.
A problem that may be parallel to or independent of UI is recurring urinary tract infection (UTI). UTI is frequently caused by the entrance of infectious microorganisms such as bacteria or yeast into the urinary tract. These microorganisms then traverse or partially traverse the urinary tract and lead to infection. This problem is especially acute in women who suffer from UI, since compression (closure) of their urethras is compromised.
A vaginal female incontinence device including an annular ring-shaped inflatable body is described in U.S. Pat. No. 5,007,894 to Enhorning. This incontinence device includes two projections configured to support the tissue of the vaginal wall, lateral and adjacent each side of the upper urethra, such that the tissue therebetween be sideways stretched to offer counter pressure to sudden increases in intra-abdominal pressure. This ring-shaped device can only be placed inside the vagina in a specific orientation, which thus requires a certain degree of proficiency for inserting it and probably also frequent refitting to place the urethra along the midline of the device between the two projections. Additionally, this device is not configured to apply direct pressure on the vaginal tissue under the urethra. It therefore understood that the placement of this annular ring-shaped device requires a practitioner, and doubtfully if a user can place it correctly inside the vagina without such assistance, and if such ring-shaped design and dimensions can provide comfort and convenience in use.